BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASYS BLOCKER

    MDR report key: 964964 · Received December 12, 2007

    Report

    Report Number
    9617544-2007-00065
    Event Type
    Malfunction
    Date Received
    December 12, 2007
    Date of Event
    November 20, 2007
    Report Date
    December 5, 2007
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K032394
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE SUPPLIED ON A SUPPLEMENTAL. LOT # LJP WAS ALSO REFERENCED, BUT IT IS UNK WHICH, IF ANY, OF THE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE PRIMARY SURGERY: IN 2007 (PEDICLE SCREW ON C4, C7, T1 ON ONE SIDE). AFTER 1 WEEK FROM THE PRIMARY SURGERY, THE ROD DISASSEMBLED AT C4. NO REVISION IS PLANNED AT THIS MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASYS BLOCKER IMPLANT NKB STRYKER SPINE BORDEAUX NA LDL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other